FDA-Device2026-01-28Class IIPROCESSING DEFECT
Edan iM50, iM60, iM70, iM80 patient monitors recalled for cybersecurity vulnerabilities
OTHERNationwide distribution
Check your Edan patient monitor for cybersecurity issues
Edan patient monitors (models iM50, iM60, iM70, and iM80) have potential cybersecurity vulnerabilities that could allow unauthorized access to the device. The FDA identified these issues and is requiring the manufacturer to address them. No injuries have been reported.
- Check if you own or operate an affected Edan monitor model (iM50, iM60, iM70, or iM80)
- Contact Edan Diagnostics or your healthcare IT department for guidance on updates or remediation steps
- Do not discontinue patient monitoring; continue using the device while awaiting instructions from Edan
Hazard
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Sold states
Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
Affected count
14550
Manufactured in
9833 Pacific Heights Blvd, San Diego, CA, United States
Products
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2026Don't want to check this manually?
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